Container for quick release packages for surgical instruments

ABSTRACT

A thermoformed blister package for a surgical instrument. The package has a tray having at least one cavity having at least one undercut and pads for quickly releasing the instrument from the cavity and package without touching the instrument. The package also has an interlocking projection for efficiently storing packages in a dispenser container.

This is a division of application Ser. No. 08/416,936, filed Apr. 4,1995, now U.S. Pat. No. 5,485,917.

TECHNICAL FIELD

The field of art to which this invention relates is packaging, inparticular packaging for endoscopic instruments.

BACKGROUND OF THE INVENTION

The use of thermoformed blister packages for packaging surgical andendoscopic surgical ("endosurgical") instruments is well-known in theart. The thermoformed blister packages typically have a plurality ofcavities formed therein for receiving and retaining a particularsurgical instrument. The cavities are typically designed to conform toeach section of the surgical instrument; for example, in the case of atrocar, a large proximal cavity will receive the handle while a longdistal cylindrical cavity will receive the trocar cannula tube andobturator. It is known that endosurgical instruments such as trocarstypically have long shafts, which enable the surgeons to access apatient's body cavity. In order to retain the instrument in thethermoformed blister package and prevent it from moving during shipping,handling, storage, sterilization and the like, it is known to includeundercuts in the blister tray. These undercuts are projections thatextend over the top of the opening of a cavity in which all or part ofan instrument is contained. The gap between the undercuts is typicallyless than the width of the opening of the cavity thereby serving toassist in preventing an instrument or part thereof from being releasedfrom the cavity.

Although the use of undercuts is effective in retaining an instrument ina cavity of a blister formed tray, there are also disadvantagesassociated with the use of undercuts. In particular, at the point of usein the operating room, it may be difficult for a scrub nurse to removean instrument from a cavity of a blister package having undercuts inorder place it in the sterile operating field. In order to remove aninstrument from a cavity having undercuts, it is typically necessary tograsp the instrument with one hand while holding the package with theother hand. An upward force applied by the scrub nurse to the instrumentcauses the undercuts to rotate in opposite directions about the cavity,thereby having the effect of widening the gap between the uppercuts andallowing the instrument to be withdrawn from the cavity. The requirementof having to grasp the instrument for removal from a blister package isdisadvantageous because it may compromise the sterility of theinstrument and/or the sterile field of the operating room. Otherdisadvantages of existing packages include difficulty in removing aninstrument efficiently and quickly from a blister package havingcavities with undercuts and the need for additional packaging componentsrequired to retain the instrument in the package when undercuts are notused. It is also known that blister packages may not have efficientstorage configurations, first of all, because of the rigid materialsused that will not conform about the product exterior and, secondly,because allowances must be made for high profile areas of the product inthe package and hand hold areas to hold the package when dispensing theinstrument. This often represents a problem since hospital storage areastypically have limited storage space available.

Therefore, what is needed in this art is a package for an endoscopicinstrument having a thermoformed blister tray with cavities havingundercuts, which has a quick-release feature wherein it is not necessaryto grasp the instrument to release it from the package, thereby possiblyeliminating the need for a scrub nurse to be present to remove a sterileinstrument and place the instrument into the sterile field during theinitial setup for a sterile procedure.

SUMMARY OF THE INVENTION

Accordingly, it is an object of the present invention to provide athermoformed blister package for a surgical instrument which has aquick-release feature.

It is yet a further object of the present invention to provide a packagewherein a sterile instrument may be quickly released from the packagewithout touching the instrument and potentially compromising itssterility.

It is yet another object of the present invention to provide a packagefor an endoscopic instrument which conserves packaging and shelf spaceby having an interlocking projection.

Accordingly, a thermoformed blister package for a surgical instrument isdisclosed. The thermoformed blister package comprises a tray having anoutwardly extending flange. At least one cavity is formed in said trayfor receiving a surgical instrument. At least one undercut extends overat least one cavity for retaining the instrument in the cavity. The trayhas means for quickly releasing the instrument from the tray. Therelease means preferably comprises two finger pads. The finger pads arelocated a sufficient distance apart along the longitudinal axis of thepackage to effectively open up the undercut by flexing the package whenthe pads are pressed and the flanges are restrained, thereby releasingthe instrument from the cavity.

Yet another aspect of the present invention is a thermoformed blisterpackage having a cavity which extends substantially below the bottom ofthe package thereby forming an interlocking projection. The cavity isskewed toward either end of the package. This feature allows thepackages to be efficiently stacked by interlocking the packages suchthat the interlocking projections are adjacent to each other.

Still yet another aspect of the present invention is the combination ofa dispensing container and a plurality of the above-described packagesstacked within the container in an interlocking manner.

Other features and advantages of the invention will become more apparentfrom the following description and accompanying drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a perspective view of a package of the present inventioncontaining a trocar wherein the lid of the package is shown in apartially peeled-open position.

FIG. 2 is an exploded perspective view of the package of the presentinvention showing a blister tray, a trocar and a cover.

FIG. 3 is a side view of a sealed package of the present inventioncontaining a conventional trocar; the interlocking projection isillustrated.

FIG. 4 is a cross-sectional of the package of FIG. 3 taken along ViewLine 4--4 showing the shaft of the trocar in a cavity having undercuts.

FIG. 5 illustrates a perspective view of a dispensing container forpackaging the packages of the present invention wherein the packages arestacked in an interlocking configuration.

FIG. 6 is a partial perspective view of a dispensing opening of thecontainer of FIG. 5 illustrating a bottom dispensing opening and a slotfor viewing the interior of the container.

FIG. 7 is a side view of the dispensing container of FIG. 5 showing inphantom packages of the present invention contained therein in aninterlocking configuration;a package of the present invention is seen asit is dispensed from the container dispensing opening; the packages areseen to have interlocking projections.

FIG. 8 is a bottom view of the package of FIG. 1 illustrating the fingerpads 60 which are pressed to quickly release an instrument from thetray.

FIG. 9 is a side view of the package of FIG. 1 after the cover has beenremoved illustrating the user's thumbs pressing the bottom finger padswhile the user's remaining fingers press along the top of the endsections of the flange of the tray.

FIG. 10 illustrates a side view of the package of FIG. 9 after the gapbetween the undercuts of the cavity containing the trocar cannula tubehas been opened sufficiently to allow the cannula to fall free from boththe cavity and the tray.

BEST MODE FOR CARRYING OUT THE INVENTION

The package 10 of the present invention is illustrated in FIGS. 1-4. Thepackage is seen to have thermoformed blister tray 20 and cover 100.Thermoformed blister tray 20 is seen to have outwardly extending flange30 and cavity 40 for receiving the handle 210 of the trocar 200. Thehandle 210 consists of the trocar obturator handle 215 interlocked withthe trocar cannula handle 220. Cavity 40 projects downwardly asufficient distance to effectively form interlocking projection 90.Interlocking projection 90 is seen to project downwardly from the bottomof tray 20 and is also seen to be skewed toward an end of the tray 20.The tray 20 is also seen to have the longitudinal cylindrical cavity 50for receiving the cannula tube 230 of the trocar 200. The cavity 50 isseen to have top extending opposed undercut projections 55 for retainingthe shaft 230 in the cavity 50 during shipping, handling, sterilization,storage, etc. A gap 58 between the undercut projections 55 issufficiently narrow to prevent the shaft 230 from dislodging from cavity50. The flange 30 is seen to have an outwardly extending end section 35,having a gripping surface 36 and opposed end section 37. Referring toFIG. 8, the bottom of the tray 20 is seen to have two finger pads 60.The cavities formed in the tray 20 of package 10 may be shaped toaccommodate various surgical instruments, although it is preferred touse the package 10 to package trocars and other endoscopic instrumentshaving elongated shafts or members. The ease of undercuts on thecavities will vary in accordance with the shape, size, weight, etc., ofthe instrument.

As seen in FIG. 8, the finger pads 60 are formed into the bottom of thetray 20. Referring also to FIGS. 9 and 10, the pads 60 are seen to besufficiently spaced along the longitudinal axis of tray 20 such thatpressing pads 60 with the thumbs of both hands while engaging the top offlange 30 with the remaining fingers of the hands along end section 35and end section 37, respectively, causes the undercuts 55 to rotateoutwardly. This causes the gap 58 to increase sufficiently toeffectively allow trocar cannula tube 230 to be released from the cavity50. The trocar 200 is then released and free to fall from the tray 20,e.g., into a sterile field, without having to manually grasp ormanipulate the trocar. The lid 100 is seen to be a generallyrectangularly shaped member, having an angulated end 105 correspondingto end flange section 35.

Referring to FIGS. 5, 6 and 7, an outer dispensing container 300 for thepackages 10 of the present invention is seen. The dispensing container300 consists of opposed front and back walls 350 and 355, respectively,opposed connecting side walls 360 and 365, and top wall 370 and bottomwall 380. The walls are preferably connected as necessary alongconventional fold lines or perforations. The package is seen to have alower end perforated portion 305 formed by score line 306, which isremovable to form dispensing outlet 320 from which the interlockedstacked packages 10 are removed. Vertical vent 310 contained in thecorner of package of 300 allows the user to determine the number ofpackages 10 remaining in the outer container 300. Referring to FIG. 7,the interlocking configuration of the packages 10 within the outercontainer 300 is seen. The packages 10 are packed in the outer container300 in a manner wherein the bottoms of adjoining packages 10 face eachother such that interlocking projections 90 of packages 10 are adjacentto each other. Thus, the use of interlocking storage packages 10 in theouter dispensing container 300 conserves space by allowing more packages10 to be stored in a container than conventional packages not havingthis interlocking feature.

The thermoformed blister packages of the present invention are formedusing conventional thermoforming equipment and conventionalthermoforming processes. The thermoforming process typically consists ofan initial stage wherein a sheet of plastic is heated to a sufficienttemperature where it is effectively formable. Then, the heated plasticsheet is placed over a mold having cavities conforming to the structureof the package. Next, a vacuum is drawn through perforations in the moldto form the plastic into a configuration which conform to the contoursof the mold. Next, the formed plastic sheet is cooled to a temperaturebelow its moldable state, and the formed component is then removed fromthe mold.

The plastic sheeting, which can be used to manufacture the thermoformedblister trays 20 of the present invention for use in packaging medicaldevices, includes suitable, conventional plastic sheeting materialsknown in the art and equivalents such as polyethyleneterephthlate(PETE), polyvinyl chloride (PVC), polypropylene(PP) andpolystyrene(PS) and the like. It is particularly preferred, whenmanufacturing the packages 20 of the present invention to usepolyethylene terephthalate. The thickness of the sheet material istypically as thin as possible but sufficiently thick to effectivelyprovide sufficient mechanical strength. The thicknesses may, forexample, vary from about 0.010 inches to about 0.060 inches.

The dispensing container 30 is made from any conventional packagingmaterials including fiber board, paper, plastics, composites and thelike having sufficient rigidity to effectively function in a package. Itis particularly preferred to use solid bleached sulphate board, claycoated newsback, clay coated kraft and the like.

The cover 100 used in the package 10 can be made from coated or uncoatedTyvek®, coated paper, non-porous plastic film and the like. The cover100 is sealed to the flange 30 using conventional sealing techniquesincluding heat sealing, pressure sealing , RF sealing, impulse sealing,ultrasonic sealing and the like and combinations thereof.

The sealed package 10 containing a trocar 200 or other medical device issterilized using conventional sterilization processes and cycles. Thepackage 10 may be sterilized using gaseous sterilants including ethyleneoxide as well as radiation. The trocar 200 may also be asepticallypackaged package 10.

There are numerous advantages associated with the packages 10 of thepresent invention. It is now possible to utilize a thermoformed blistertray for a surgical instrument which has a quick-release feature suchthat the instrument can be removed quickly and efficiently from thepackage without having to grasp the instrument by merely manipulatingthe exterior of the package. Another advantage of the packages 10 of thepresent invention is that when stacked in accordance with thepreviously-mentioned configuration in an outer container of the presentinvention, the shelf space required for storage of the packages isreduced.

Although this invention has been shown and described with respect todetailed embodiments thereof, it will be understood by those skilled inthe art that various changes in form and detail thereof may be madewithout departing from the spirit and scope of the claimed invention.

What is claimed:
 1. A dispenser for a plurality of thermoformed blisterpackages comprising:a container comprising opposed front and back panelsconnected by a pair of opposed side, panels; a top panel; a bottom panela dispensing opening in the bottom of the front panel; and, a ventopening in at least one side;wherein the dispenser contains a pluralityof interlocking, thermoformed blister packages comprising: a cover; and,a tray, wherein the tray comprises: a member having a top, a bottom anda center: a flange extending outwardly from the tray; a plurality ofcavities in said tray for receiving a surgical instrument wherein eachsaid cavity has a top opening wherein at least one of the cavities hasat least one undercut extending from the tray adjacent to the top of theat least one cavity for retaining at least a portion of a saidinstrument within the cavity, each undercut partially extending into thetop opening of the cavity thereby forming a gap; and, means for quicklyreleasing a said instrument from the tray without touching theinstrument wherein the means for quickly releasing the instrument fromthe tray comprises two finger pads extending from the bottom of the trayand spaced sufficiently apart to open up the gap sufficient to releasethe instrument when the pads are pressed while holding the outwardlyextending flange, wherein the bottom of the tray beneath one cavity insaid tray extends downwardly to form an interlocking projection therebydividing the bottom of the tray into an interlocking projection and aninterlocking bottom section, wherein said projection is offset from thecenter of the tray such that the interlocking projection andinterlocking bottom section of one package can interlock with theinterlocking projection and interlocking bottom section of anotherpackage. wherein the packages are stacked within the container in a traybottom-to-bottom configuration such that the interlocking projectionsand bottoms of each package are adjacent to and interlock with eachother.